FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPUTERIZED RADIATION TREATMENT PLANNING SYS
K Number: K853964
·
Decision Dec 5, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
87
Applicant Total
23
Review Days
80
Basic Information
- Device Name
- COMPUTERIZED RADIATION TREATMENT PLANNING SYS
- K Number
- K853964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- COMPUTERIZED MEDICAL SYSTEMS, INC.
- Date Received
- September 16, 1985
- Decision Date
- December 5, 1985
- Product Code
- LHN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHN), ordered by most recent decision date.
eMotus Respiratory Motion Management System
FDA 510(k)
FDA Class 2
·Radiology
P-Cure Proton Therapy System (PPTS)
FDA 510(k)
FDA Class 2
·Radiology
PROBEAT-FR
FDA 510(k)
FDA Class 2
·Radiology
ProBeam 360° Proton Therapy System v2.0 (Multiroom)
FDA 510(k)
FDA Class 2
·Radiology
P-Cure Proton Beam Therapy System
FDA 510(k)
FDA Class 2
·Radiology
Small Field Applicator
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by COMPUTERIZED MEDICAL SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K110730 | MONACO RTP SYSTEM | Jun 24, 2011 | Substantially Equivalent |
| K102216 | XIO RTP SYSTEM | Oct 1, 2010 | Substantially Equivalent |
| K092132 | XIO RTP SYSTEM | Sep 24, 2009 | Substantially Equivalent |
| K091179 | MONACO RTP SYSTEM, VMAT OPTION | Jul 16, 2009 | Substantially Equivalent |
| K080799 | ATLAS-BASED AUTOSEGMENTATION | Aug 7, 2008 | Substantially Equivalent |
| K071938 | MONACO RTP SYSTEM | Oct 1, 2007 | Substantially Equivalent |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | Dec 2, 2003 | Substantially Equivalent |
| K032100 | I-BEAM | Oct 2, 2003 | Substantially Equivalent |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | Oct 8, 2002 | Substantially Equivalent |
| K013112 | FOCAL SIM | Dec 5, 2001 | Substantially Equivalent |